Events

Recall of FLEXCATH STEERABLE SHEATH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC CRYOCATH LP.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64646
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This field notification is to inform affected customers of an observation related to a potential leak in the hemostatic valve of the flexcath 12 steerable sheath model 3fc12 and provided information on the best approach to recognize and manage the observation. in may 2011 the rate of occurrence of hemostatic valve leaking related issues rose from 0.35% to 2.47%. the reported failures are hemostatic valve leaking and air ingress during aspiration. due to the design difference of the 12 french sheath from the 10 french sheath and the increase in the rate of occurrence being specifically related to the 12 french model of the flexcath sheath the communication is being focused on the 12 french sheath model.

Device

FLEXCATH STEERABLE SHEATH
  • Model / Serial
    Model Catalog: 3FC12 (Lot serial: >10 numbers contact mfg)
  • Product Description
    FLEXCATH STEERABLE SHEATH Model 3FC12
  • Manufacturer
    MEDTRONIC CRYOCATH LP

Manufacturer

MEDTRONIC CRYOCATH LP
  • Manufacturer Address
    KIRKLAND
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC